Limited-use tool disposable enclosure

ABSTRACT

A re-usable medical procedure power tool includes enclosed housing including a tool attachment portion, a handle portion connected to a tool attachment portion and a power portion. A removable, single use, contamination-blocking cover substantially covering the housing, the handle portion the power portion. The cover also includes an opening adjacent an exposed first end of the tool attachment portion, whereby a tool accessory is selectively attached to and removed from the first end of the tool attachment portion during a medical procedure.

This application is a Continuation of Non-Provisional application Ser.No. 17/207,898 filed Mar. 22, 2021, which is a Continuation ofNon-Provisional application Ser. No. 15/965,887 filed Apr. 28, 2018, nowU.S. Pat. No. 10,952,804, which is a Continuation of Non-Provisionalapplication Ser. No. 14/551,080 filed Nov. 24, 2014, now abandoned,which is related to and claims priority to Provisional Application No.61/913,266 filed Dec. 7, 2013.

BACKGROUND

This disclosure relates generally to limited-use power tools and moreparticularly to an enclosure for such tools during use in medicalprocedures; the enclosure being removed and discarded duringreprocessing of the tools for subsequent re-use.

Important factors for any surgical instrument include sterility, cost ofacquisition, maintenance, and reliability during use in the surgicalsuite. Each of these factors can have a significant impact on the costof medical care for both the patient and the provider.

In recent years, there has been significant focus on the ever-increasingcost of medical care. These cost increases have led to skyrocketinginsurance premiums, reduced coverage, reduced reimbursements, increasedfees for services, severe reductions in services for some patient groupsby some providers, and unfortunately an apparent increase in infectionsand medical mishaps.

In an effort to reduce costs and improve profitability, both serviceproviders and medical device suppliers are continuously looking for waysto streamline procedures, reduce time, cost, and risk from theirproducts and services without reducing the quality of the products orservices they provide to their customers. One area to benefit from thesesavings and improvements has been in the orthopedic surgical fieldthrough the use of high precision, battery powered surgicalinstrumentation. In the late 1960's and early 1970's battery-operateddrills were bulky, ill-balanced and required multiple batteries toperform some surgeries due to the limited energy storage capacity andpoor efficiency of the electric motors.

Since then, manufacturers have attempted to make batteries moreefficient with higher energy storage capacity, reduced size, andimproved rechargeable lifespans. Likewise, motor housings such as sawand drill bodies have become more ergonomic, balanced, lightweight andenergy efficient. As with many standard hand tools having multiplemoving components, instrument manufacturers have reduced weight byutilizing lighter materials such as plastic housings, and gears, and putweight reducing apertures in what were previously solid housings. Insome cases, standard mountings for attachments have been replaced withmodular fittings, allowing for greater interchangeability and componentselections. Additionally, manufacturers have attempted to improveelectrical components by upgrading them with more modern componentswherever possible.

All of these improvements in equipment construction have improvedefficiencies, costs and quality in some areas while at the same timeincreasing costs for acquisition, maintenance and increasing risks inother ways that were not previously seen or predicted. Often times costand quality can be inversely proportional to one another. One example ofthe increased cost and patient risk is seen in the cleaning andmaintenance of instruments.

Recent published reports suggest that many of the surgical instrumentsused in operations were not being cleaned and/or sterilizedappropriately in the very hospital facilities that were established andtasked for that purpose. In numerous reports, following cleaning andsterilization, it was noted that upon closer secondary inspection, theinside of small diameter cannulas and intricate mini-components ofarthroscopic shavers that are used for many of today's minimallyinvasive procedures, contained human tissue and bone fragments fromprevious surgeries. In other cases, modular components of drills andsaws such as chucks, drill bits and blades were found to have similardebris or pieces of cleaning brushes and/or bristles embedded in or onthem. These investigations have demonstrated that in most cases theinstruments were not cleaned according to manufacturer's specificationswhich has likely lead to many documented cases of serious, multiple,serial infections for subsequent patients. A pilot program conducted bythe Centers for Medicare and Medicaid Services (Schaefer et al., 2010;JAMA 2010; 303(22):2273-2279) inspected 1500 outpatient surgery centersand found that 28% had been cited for infectious control deficienciesassociated with equipment cleaning and sterilization. The costs to thepatients and the hospitals in both expense and liability to deal withthese infections can be and has been staggering.

In other cases, critical battery-operated, motorized tools such asdrills or bone saws have ceased to function due to dead batteries thatno longer maintain their capacity to hold a charge, or due to internalpart failure, often attributable to overuse or lack of propermaintenance. The resultant downtime in the operating suite is extremelycostly, as the procedure step must be put on hold while replacement orsubstitute tools are obtained. Wait times may often exceed 20-30minutes, resulting in additional anesthesia exposure for the patient,additional operating room time (charged to the patient) and potentialdelays to other procedures where the replacement or substitute equipmenthad been scheduled for use in a later procedure. Recent estimates (2005)establish the average cost of operating room time to range between$62/min. (range $21.80-$133.12) depending on the procedure. Thesefigures did not include extra resources provided by the hospital forspecial, non-routine situations which often occur during standardprocedures, and did not include the surgeon and anesthesia providerfees, (anesthesia fees are estimated to be $4/min; range $2.20-$6.10).

Hospitals and instrument manufacturers are continuously attempting tofind improved ways to reduce risk associated with infection in general,and more recently, specifically from improperly cleaned instruments. Oneapproach has been to use more disposable, single-use instruments such asdrills, saw blades and plastic cannulas. Additionally, many laparoscopicdevices such as, surgical staplers and trocars, are designed as singleuse items that are intended to be immediately disposed of after use.Unfortunately, at today's acquisition costs, the total cost of ownershipand benefits are not always clear for high-use battery-operated,motorized instruments such as saws, drills and reamers used inorthopedic procedures and the idea of disposable powered instruments hasnot been readily embraced.

A recent trend in the medical community is reprocessing of single usemedical instruments, by parties other than the original equipmentmanufacturer, instead of discarding them after use. During reprocessing,the medical instruments are disassembled, cleaned and sterilized. Theyare then reassembled for future use. However, because the medicalinstruments reprocessed for further use are specifically provided foruse during a single procedure, the performance of the medicalinstruments tends to decline after reprocessing, because the componentsmaking up the medical instrument are not adapted for multiple uses andwill degrade in performance when used beyond their intended life span.For example, reprocessing of the cutting devices on trocars is intendedto extend these devices beyond their intended mission life, but oftenresults in duller cutting edges on the blades because neither thematerials used nor the reprocessing method can restore the device to theoriginal manufacturing specifications. A greater force, therefore, isneeded to make an initial incision, causing more trauma to the patient.In addition, the use of greater force increases the potential for errorduring the surgical procedure.

Most hospitals and surgery centers buy high-use, reusable motorized,pneumatic, wired or battery-operated, orthopedic surgical equipment andare expected to clean, sterilize, and maintain them internally withinthe hospital. Unfortunately, the technicians hired to perform this workare typically not qualified or trained to perform this work adequatelyfor the many varieties of powered instruments used. Further,manufacturers rarely provide the hospital/client with the training ordiagnostic equipment necessary to evaluate or test the equipment. Oftentimes the hospital employees responsible for cleaning and maintenanceare not technicians at all, being paid slightly more than minimum wage,working at a fast pace to merely wash, count, and reload instrumentsinto their appropriate system trays and flash sterilize them as quicklyas possible, in an effort to keep the equipment in rotation in thehospital operating rooms, where higher throughput dictates profitabilityfor the hospital or surgery center.

As a result of high throughput requirements, general maintenance israrely done, and preventative monitoring and maintenance is almost neverdone on this type of equipment. Hospital budgets for internalmaintenance of equipment are generally geared toward high-end,multi-million-dollar capital equipment such as x-ray and radiologicalequipment. It is generally assumed that it is faster, simpler, and moreeconomical for the hospital to wait for hand-held instruments, such asdrills, saws, and reamers to fail, then, send them back to themanufacturer for repair or replacement.

Thus it has become apparent that there is a need for an improved systemof cost-effective, battery-operated, motorized tools in conjunction withbetter cleaning and maintenance protocols which can provide thehospital, surgeon, and most importantly, the patient, with a higherdegree of efficiency and cleanliness while reducing risk and keeping thecosts of cleaning, maintenance, and repair as low as possible.

SUMMARY

Accordingly, a reusable medical procedure power tool cover comprises aremovable, single use contamination blocking material substantiallycovering the power tool, wherein the power tool includes a controlportion, a power access portion and an attachment access portion. Afirst opening is provided in the cover adjacent the attachment accessportion, whereby a tool accessory is selectively attached to and removedfrom a first end of the tool attachment portion during a medicalprocedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective, assembly view illustrating an embodiment of apower tool having a housing and a removable, single use, hardshell orsoftshell wrap or cover formed of a contamination blocking material.

FIG. 2 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is a stretch membrane.

FIGS. 3 a and 3 b are perspective assembly views illustratingembodiments of the power tool of FIG. 1 wherein the covers include ashrink-wrap tape and a shrink-wrap tube respectively.

FIG. 4 is a perspective assembly view illustrating an embodiment of amechanical sub-frame of a power tool having no housing and wherein thecover is a disposable hardshell.

FIG. 5 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is spray-on applied.

FIG. 6 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is dip applied.

FIG. 7 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is a header bag.

FIG. 8 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is a pre-cut wrap.

FIG. 9 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is double layer stretch membrane.

FIG. 10 is a perspective view illustrating an embodiment of the powertool housing as viewed from the backside of the tool and having asealable door removed to expose a cavity to receive a portable battery.

FIG. 11 is a perspective view illustrating the tool of FIG. 10 havingthe sealable door installed.

FIG. 12 is a perspective view illustrating an embodiment of a sterilizedshipping tray and lid containing the power tool.

DETAILED DESCRIPTION

The embodiment of FIG. 1 illustrates an exemplary power tool 10 for usein medical procedures such as surgical procedures. A removable, singleuse, contamination-blocking cover 12 is provided for blocking excessivecontamination of the power tool 10 during use. The cover 12 isreplaceable, e.g.: after the procedure, the cover 12 may be removed andreplaced by a new cover 12.

The tool 10 includes a housing 14 comprising a handle portion 16 and inthis example, a power source portion such as a receiver 18 for aportable battery pack and a tool attachment portion 20 having a chuck 21provided for releasably receiving and holding an attachment tool such asa drill bit or a saw blade. The handle 16 includes a control portionincluding but not limited to an actuating trigger 22, a trigger lock 24and a forward-reverse switch, all of which may not be visible in FIG. 1. The attachment point of a saw blade may vary depending on whether itis a reciprocating or oscillating blade.

The cover 12 preferably includes a two-piece hard or soft outer shellincluding portions 12 a and 12 b. The tool 10 is illustrated at 10 aprior to application of the cover 12, and is illustrated at 10 b afterapplication of the cover 12. A first opening 12 c is provided in cover12 adjacent chuck 21 when the cover is applied to the tool 10. A secondopening 12 d, which may be closed by a sealable door 19, is provided inpower source portion 18. Regardless of the material used for the cover12, a flexible portion 12 e of the cover 12 is provided on the handle 16to provide a user with a tactile feel and operable movement of forexample, the trigger 22 and the trigger lock 24.

The replaceable cover 12 is applied to tool 10 by a tool re-processor.Once the tool 10 is used in a procedure, the cover has becomecontaminated along with portions of the tool 10 which are adjacent theopenings 12 c, 12 d. The tool 10, including cover 12, is returned to thetool re-processor where the cover 12 is removed and discarded. The tool10 is then cleaned and a new cover 12 is mounted on the tool 10,rendering the tool 10 ready for re-use.

More specific information regarding the tool 10 and cover 12 of the FIG.1 embodiment as described above are set forth below as follows:

-   -   a. Existing product or new product uses a rigid body mechanical        housing 14 in conjunction with either a hard or soft/flexible        shell outer shield 12 that covers and protects the majority of        the tool 10 from contamination by blood/bone/tissue during a        procedure. Combinations of materials such as a hard shell with        flexible inserted areas for controls actuation are also        contained in this area. Additional reinforcements or seals can        be used in high stress areas.        -   i. Materials and alloys/laminates of these materials            appropriate for this concept include but are not limited to:            -   a. PETG & A/PET;            -   b. Polystyrene;            -   c. Acrylic;            -   d. Polycarbonate;            -   e. ABS;            -   f. Nylon;            -   g. Polyolefin;            -   h. Polyetheretherketone PEEK;            -   i. Polyetherimide PEI;            -   j. Polyetersulfone PES;            -   k. Polyvinylidene PVDF;            -   l. Polymethylpentene PMP;            -   m. Polysulfone PSO;            -   n. Ethylene-chlorotrifluoroethylene ECTFE;            -   o. Metals;        -   ii. Soft/flexible outer shell can be produced using            injection molding, thermoforming, dip molding, compression            molding or other processes. Materials and alloys of these            materials appropriate for this concept include but are not            limited to:            -   a. Synthetic Paper;            -   b. C-Flex;            -   c. Flexible PVC;            -   d. Polycarbonate;            -   e. Polyester;            -   f. Polyethylene;            -   g. Polypropylene;            -   h. Nylon;            -   i. Polyolefin;        -   b. Methods appropriate for fastening the outer shell            to/around the inner structure include but are not limited            to:            -   i. Fasteners such as:                -   1. Screws;                -   2. Rivets;                -   3. Bolts;            -   ii. Molded features such as:                -   1. Clips;                -   2. Press fits;                -   3. Slip fits;            -   iii. Adhesive in multiple forms:                -   1. Tape;                -   2. Glue;                -   3. Pressure sensitive adhesive;                -   4. Hot melt adhesives;                -   5. Contact adhesives;            -   iv. Secondary operations:                -   1. Heat Seal;                -   2. Pierce;

Several further embodiments are described below. More specificinformation regarding the tool 10 and a stretch membrane cover 12including upper member 12 a and lower member 12 b, of the FIG. 2embodiment is described below as follows:

-   -   a. This embodiment uses a rigid body mechanical housing 14 in        conjunction with a highly stretchable membrane 12 (balloon like)        to cover and protect the tool 10 from contamination by        blood/bone/tissue during a procedure. This cover 12 is a        removable, single use cover of contamination blocking material.        Single and multiple layer configurations can be considered for        this version. Single or multiple membranes may be used to        protect various areas of the tool 10 (main body vs. battery pack        allowing access to battery pack at the start of a procedure).        Variable wall thickness or reinforcements can be used in high        stress areas. Members 12 a and 12 b are stretched over housing        14 and combined to form cover 12. Tool 10 is shown at 10 a prior        to application of cover 12 and is shown at 10 b after the        application of cover 12.        -   i. Flexible membranes can be produced using blow molding,            dip molding, thermoforming, or other processes. Members 12 a            and 12 b are stretched over housing 14 and combined to form            cover 12. Tool 10 is shown at 10 a prior to application of            cover 12 and is shown at 10 b after the application of cover            12.            -   1. Materials and alloys of these materials appropriate                for this concept include but are not limited to:                -   a. Silicone;                -   b. Latex Rubber;                -   c. Synthetic Rubber;                -   d. Polychloroprene;                -   e. Flexible PVC;        -   b. Methods appropriate for applying the membrane around the            outer shell include but are not limited to:            -   i. Stretching:                -   1. Manually;                -   2. Automated;                -   3. Individual sections (i.e.: main body separate                    from Battery Pack area);            -   ii. Secondary operation:                -   1. Additional seals/retention elements at operation                    interfaces such as drill chuck or saw adaptor;                -   2. Additional tape reinforcements in high stress                    areas

More specific information regarding the tool 10 and a shrink wrap cover12, FIGS. 3 a, 3 b , is described below as follows:

-   -   a. This embodiment uses a rigid body mechanical housing 14 in        conjunction with a secondary shrink-wrap element 12 to cover and        protect the device from contamination by blood/bone/tissue        during a procedure. Cover 12 is a removable, single-use cover of        contamination blocking material. Single and multiple layer        configurations can be considered for this version (see        considerations for transport as non-biohazard state). Single or        multiple wraps may be used to protect various areas of the tool        10 (main body vs. battery pack allowing access to battery pack        at the start of a procedure). Additional reinforcements or seals        can be used in high stress areas. Shrink methods can include        both heat application or a chilling operation depending on the        type of shrink wrap utilized. Tool 10 is shown at 10 a prior to        application of cover 12 and is shown at 10 b after the        application of cover 12 and shrink activation, FIGS. 3 a , 3 b.        -   i. Flexible shrink-wrap can be produced using extrusion            processes, and are available in tape, FIG. 3 a , sheet or            tube form, FIG. 3 b and can be either heat or cold activated            to create the wrap required for device isolation. Some tape            applications carry an adhesive layer. The shrink-wrap tube            cover 12 x, FIG. 3 b , is trimmed at 12 y after shrink            activation at 12 z. Shrink-wrap tape, FIG. 3 a is shown            prior to wrapping at 12 x and after wrapping and shrink            activation at 12 y.            -   1. Materials and alloys/laminates of these materials                appropriate for this concept include but are not limited                to:                -   a. Acetate;                -   b. Polyethylene;                -   c. PVC;                -   d. Polyester;                -   e. Polyolefin;                -   f. Polypropylene;    -   b. Methods appropriate for applying the membrane around the        outer shell include but are not limited to:        -   i. Tape Wrapping:            -   1. Manually;            -   2. Automated;            -   3. Individual sections (i.e.: main body separate from                Battery Pack area);        -   ii. Film Wrap:            -   1. Manually;            -   2. Automated;            -   3. Individual sections (i.e.: main body separate from                Battery Pack area);        -   iii. Secondary operations:            -   1. Heat seal for complex geometries;            -   2. Shrink Tunnel;            -   3. Heat Gun;            -   4. Refrigeration;            -   5. Additional tape reinforcements in high stress areas;            -   6. Adhesive application to tape wrap;

In FIG. 4 , an embodiment utilizes no traditional housing 14, asdescribed above, but provides the inner frame and working parts as tool110 and the outer hard-shell cover 12 of tool 110 is provided as adisposable cover, as described below:

-   -   a. This embodiment uses a rigid sub-frame 110 carrying all        mechanical components. The hard-shell cover 12 has minimal        mechanical content and is used as a disposable single-use        housing of a contamination blocking material to protect the        mechanical components from contamination by blood/bone/tissue        during a procedure. Cover 12 comprises cover portions 12 a, 12        b. The sub-frame and mechanical components are intended for        multiple re-use. This configuration may also be used in        conjunction with a soft/flexible outer shell allowing for return        of the device in a non-biohazard state. Combinations of        materials such as hard shell with flexible inserted areas for        controls actuation are also contained in this area. Additional        reinforcements or seals can be used in areas subject to        contaminant intrusion. Thus, the hard shell, single-use        disposable cover 12 functions as a combination previously        provided by a traditional housing 14 and cover 12.        -   i. Hard outer shells can be produced using injection            molding, thermoforming, or other processes.            -   I. Materials and alloys/laminates of these materials                appropriate for this concept include but are not limited                to:                -   a. PETG & A/PET;                -   b. Polystyrene;                -   c. Acrylic;                -   d. Polycarbonate;                -   e. ABS;                -   f. Nylon;                -   g. Polyolefin;                -   h. Polyetheretherketone PEEK;                -   i. Polyetherimide PEI;                -   j. Polyetersulfone PES;                -   k. Polyvinylidene PVDF;                -   l. Polymethylpentene PMP;                -   m. Polysulfone PSO;                -   n. Ethylene-chlorotrifluoroethylene ECTFE;                -   o. Metals;    -   b. Methods appropriate for fastening the outer shell to/around        the inner structure include but are no limited to:        -   i. Fasteners such as:            -   1. Screws;            -   2. Rivets;            -   3. Bolts;        -   ii. Molded features such as:            -   1. Clips;            -   2. Press fits;            -   3. Slip fits;        -   iii. Secondary operation:            -   1. Tape;            -   2. Glue;            -   3. Pressure sensitive adhesive;            -   4. Hot melt adhesives;            -   5. Contact adhesives;            -   6. Heat seal;            -   7. Pierce;

In FIG. 5 , another embodiment includes a tool 10 having a protectivespray cover 12 further described as follows:

-   -   a. This embodiment uses a rigid body mechanical housing 14 in        conjunction with a secondary spray-on protective layer 12 to        cover and protect the tool 10 from contamination by        blood/bone/tissue during a procedure. Single and multiple layer        configurations can be considered for this version by using a        release layer between subsequent spray applications. This        configuration may be used in conjunction with previously        described protection systems to allow access to power source        portion 18 at the start of a procedure. Additional        reinforcements or seals can be used in areas subject to        contaminant intrusion. Layer 12 is a removable, single-use cover        of contamination blocking material.        -   i. Spray on protective layers can be applied either manually            or automatically. Specific areas not to be coated can be            masked to ensure correct device function. It may also be            desirable to coat individual components prior to assembly to            minimize masking issues.            -   1. Materials and alloys/laminates of these materials                appropriate for this concept include but are not limited                to:                -   a. Natural rubber;                -   b. Synthetic rubber;                -   c. Polyurethane;                -   d. Acrylic;                -   e. Polyethylene;                -   f. PVC;                -   g. Polyester;                -   h. Polyolefin;                -   i. Polypropylene;    -   b. Methods appropriate for applying the membrane around the        outer shell include but are not limited to:        -   i. Aerosol application:            -   1. Manually;            -   2. Automated;            -   3. Individual section (i.e.: main body separate from                Battery Pack area);        -   ii. Secondary operations:            -   1. Drying/curing;

In FIG. 6 , another embodiment includes a tool 10 having a protectivedip layer as a cover 12 further described as follows:

-   -   a. This embodiment uses a rigid body mechanical housing in        conjunction with a secondary dipping operation to apply a        protective layer 12 intended to cover and protect the tool 10        from contamination by blood/bone/tissue during a procedure.        Single and multiple layer configurations can be considered for        this version by using a release layer between subsequent dip        applications. This configuration may be used in conjunction with        previously described protection systems to allow access to power        source portion 18 at the start of a procedure. Additional        reinforcements or seals can be used in areas subject to        contaminant intrusion. Layer 12 is a removable, single-use cover        of contamination blocking material.        -   i. Dip protective layers can be applied either manually or            automatically. Specific areas not to be coated can be masked            to ensure correct device function.            -   1. Materials and alloys/laminates of these materials                appropriate for this concept include but are not limited                to:            -   a. Natural rubber;            -   b. Synthetic rubber;            -   c. Polyurethane;            -   d. Acrylic;            -   e. Polyethylene;            -   f. PVC;            -   g. Polyester;            -   h. Polyolefin;            -   i. Polypropylene;    -   b. Methods appropriate for applying the membrane around the        outer shell include but are not limited to:        -   i. Dip application:            -   1. Manually;            -   2. Automated;            -   3. Individual sections (i.e.: main body separate from                Battery Pack area);            -   4. Secondary operations drying/curing;

In FIG. 7 , another embodiment includes a tool 10 with battery door 19providing access to power source portion 18 and having a protectiveheader bag formed to shape as a cover 12 further described as follows:

-   -   a. This embodiment uses a rigid body mechanical housing 14 in        conjunction with a formed header bag outer shielding cover 12        that protects the majority of the tool 10 from contamination by        blood/bone/tissue during a procedure. Additional reinforcements        or seals can be used in high stress areas. Header bag cover 12        comprises a removable, single-use cover of contamination        blocking material.        -   i. Header bag cover 12 can be produced using an extrusion            process for the base material with secondary forming and            sealing operations to create a sealed enclosure. The header            bag 12 is a shaped, non-stretchable, bag-like shell loosely            fitted over the housing 14.            -   1. Materials and alloys of these materials appropriate                for this concept include but are not limited to:                -   a. Synthetic paper;                -   b. C-Flex;                -   c. Flexible PVC;                -   d. Polycarbonate;                -   e. Polyester;                -   f. Polyethylene;                -   g. Polypropylene;                -   h. Nylon;                -   i. Polyolefin;    -   b. Methods appropriate for fastening the header bag to/around        the inner structure include but are not limited to:        -   i. Adhesive in multiple forms            -   1. Tape;            -   2. Glue;            -   3. Pressure sensitive adhesive;            -   4. Hot melt adhesives;            -   5. Contact adhesives;

In FIG. 8 , another embodiment includes a tool 10 having a protectivedie cut wrap as a cover 12 further described as follows:

-   -   a. This embodiment uses a rigid body mechanical housing 14 in        conjunction with a Precut Wrap outer shielding cover 12 that        once applied protects the majority of the tool 10 from        contamination by blood/bone/tissue during a procedure.        Additional reinforcements or seals can be used in high stress        areas or areas vulnerable to contaminant intrusion.        -   i. The device can be produced using an extrusion process for            the base material with secondary cutting operations and            sealing components added to provide a method for creating a            sealed enclosure.            -   1. Materials and alloys of these materials appropriate                for this concept include but are not limited to:                -   a. Synthetic paper;                -   b. C-Flex;                -   c. Flexible PCV;                -   d. Polycarbonate;                -   e. Polyester;                -   f. Polyethylene;                -   g. Polypropylene;                -   h. Nylon;                -   i. Polyolefin;    -   b. Methods for cutting the wrap to conform to the device include        but are not limited to:        -   i. Manual cutting;        -   ii. Die cutting;        -   iii. Rotary cutting;    -   c. Methods appropriate for securing the wrap to/around the        device include but are not limited to:        -   i. Creation of appropriate flattened geometry that once            wrapped conforms to the geometry of the device.        -   ii. Adhesive in multiple forms:            -   1. Tape;            -   2. Glue;            -   3. Pressure sensitive adhesive;            -   4. Hot melt adhesives;            -   5. Contact adhesives;

In FIG. 9 , similar to FIG. 2 , another embodiment discloses a powertool 10 including a first inner stretch membrane cover 112 and a secondouter stretch membrane cover 212. This embodiment adds the outer cover212 so that after use of the tool 10, the outer cover 212 is removed andthe inner membrane 112 stays in place on the tool 10. This embodimentenables shipping the used tool to a re-processor so as to avoid shippinga biohazard product. This embodiment is further described as follows:

-   -   a. This embodiment uses a rigid body mechanical housing 14 in        conjunction with a two-layer soft/flexible shell outer cover 112        and 212 that protects the majority of the device from        contamination by blood/bone/tissue during a procedure. Following        the procedure and before return shipment of the device the        outermost contaminated cover 212 is removed presenting the inner        cover 112 that is a non-biohazard product and can economically        be returned for re-processing.

In FIG. 10 , tool housing 14, including tool attachment portion 20,handle portion 16 and power source portion 18 are illustrated from abackside perspective. The power source portion 18, as stated above, maybe closed by the sealable door 19, shown removed. A cavity 25 in powersource portion 18 may receive a battery on-site when the sterilized toolis being made ready for use. When sterilized, cavity 25 is exposed dueto door 19 being removed and thus, the interior or cavity 25 of thepower source portion 18 is also sterile. In FIG. 11 , door 19 isillustrated in attachment with power source portion 18, therebysealingly closing cavity 25. Also, a rear cannulation opening 23, FIGS.10 and 11 , not required for saw blade attachment tools, is shown on abackside wall or surface of tool attachment portion 20 opposite a frontsidewall where chuck 21 is located. In this manner, a guide wire or pincan be fed through the tool attachment portion 20 via the cannulationopening 23 and exit via the chuck end for use with a cannulatedattachment. A seal 23 a, is provided to seal opening 23. The seal 23 amay be either a removable seal or a penetratable seal.

The limited use tool 10, FIG. 12 , is returned to a re-supplier orre-processor to be prepared for re-use by packaging and sterilizing thetool. The single-use, contamination-blocking cover 12 is removed. Duringrepackaging, the tool 10 is placed in a partitioned tray 300 forshipping. Also, the removable, sealing access door 19 is placed in thetray 300 to be used after a battery is placed in a cavity within thepower source portion 18 on-site. The tray 300, containing the tool 10,access door 19 and a handle 305 available for two-handed operation(optional), are trayed and covered with a Tyvek lid or cover 310. Then aknown ETO sterilization process, or other suitable process, sterilizesthe contents of tray 300 in a gas chamber. Typically, a substantialnumber of the trayed tools are sterilized together for efficiency.Repackaged, sterilized trays 300 containing the tool 10 and access door19 are then shipped to the user. When used, a battery, stored at theuser's surgical facility is placed into the sterile cavity 25 in thepower portion 18. The sterile door 19 is then installed in the accessopening of cavity 25 (discussed above, see also FIG. 10 ).

The present disclosure has recognized and addressed many of theforegoing limitations and drawbacks of others concerning the need toprovide hospitals and surgery centers with an improved, more reliablesystem of cost-effective, battery-operated, motorized tools inconjunction with better cleaning and maintenance protocols. In practice,the disclosed tooling system utilizes a concept called limited-use tools(LUT) and specifically, a new cover or enclosure system to makereprocessing of the LUT more efficient. This cover or enclosure would beused only once in the operating room, then would be removed anddiscarded at the reprocessing facility. A new, single-use enclosurewould be installed at the reprocessing facility prior to final testing,packaging and re-sterilization of the LUT. The term “limited-use” asapplied to orthopedic surgical tools can mean having a limited usefullife, or a restricted lifespan for intended use. Preferably in thiscontext, limited-use is intended to mean the number of surgeries wherethe useful life of the tool ranges from more than one use to less than50 surgeries, and more preferably where the useful life of the toolranges from more than one use to less than 30 surgeries, and mostpreferably where the useful life of the tool ranges from more than oneuse to less than 20 surgeries.

In a broad respect this disclosure teaches a method of improving (i.e.:reducing) potential risk factors associated with infection control, andreduction of potential disease and infection transmission due to lapsesin cleaning and infection control associated with routine maintenance ofreusable powered surgical instruments. In another broad respect, thedisclosure teaches a method of processing battery-operated tools used insurgery, to improve the cleanliness of instruments used in multiplesurgical procedures and reduce the potential for disease and infectiontransmission due to lapses in cleaning and infection control proceduresbetween procedures. In yet another broad respect, the disclosure teachesa method of logistical process of powered tools to improve cleanliness,operational efficiencies and performance. Still further it is to beunderstood that although this disclosure discusses the invention interms of battery-operated tools, one skilled in the art would fullyappreciate that this disclosure has similar application to anypneumatic, wired or electric wall socket-powered instruments as well.

Although illustrative embodiments have been shown and described, a widerange of modification, change and substitution is contemplated in theforegoing disclosure and in some instances, some features of theembodiments may be employed without a corresponding use of otherfeatures. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the scope of theembodiments disclosed herein.

What is claimed is:
 1. A method of providing a limited-use, reusablemedical power tool comprising a combination of re-useable and disposablecomponents; wherein the disposable components can be removed andreplaced after each medical procedure if needed, prior to cleaning,repackaging and re-sterilization of the power tool, and wherein thenumber of surgeries where the useful life of the tool ranges from morethan one use to less than 50 surgeries.
 2. The method of claim 1,wherein said reusable components comprise: internal mechanicalcomponents including a tool attachment portion for receiving and holdingan attachment tool such as a chuck or blade adapter for releasablyreceiving and holding a drill bit or saw blade; a handle portioncomprising an actuating trigger; and a power source portion for abattery pack; wherein the handle portion including a flexible tactilefeel portion allows for operable movement of an associated triggerattached to the handle portion, and wherein said disposable componentsare selected from the group consisting essentially of: an outer shellmounted over the mechanical components, the outer shell being aconforming contamination blocking outer shell; flexible membranes; orseals between the internal mechanical components and the outer shell ora tool attachment portion; or fasteners; or molded features; oradhesives in multiple forms; or a trigger; or a battery; or a chuck orblade adapter; or a forward/reverse switch; wherein the reusableinternal mechanical components having a first shape and the conformingcontamination blocking outer shell having a second shape substantiallymatching and substantially covering the first shape such that the outershell includes a tool attachment portion, a handle portion and a powersource portion.
 3. The method of claim 2, further comprising providing asecondary contamination blocking element, wrap, bag or layer to coverand further protect the limited-use, reusable medicalbiohazard-contaminated power tool for return of the tool to a toolre-processor.
 4. The method of claim 3, wherein said secondarycontamination blocking element, wrap, bag or layer comprises: a tapewrap; a film wrap; a header bag; synthetic paper; C-Flex; Flexible PVC;Polycarbonate; Polyester; Polyethylene; Polypropylene; Nylon;Polyolefin; a shrink wrap; a spray-on protective layer; a dip protectivelayer; or a pre-cut wrap layer.
 5. The method of claim 2, wherein thefasteners comprise: screws; rivets; or bolts.
 6. The method of claim 2,wherein the molded features comprise: clips; press-fits; or slip-fits.7. The method of claim 2, wherein the adhesives in multiple formscomprise: tape; or glue; or pressure-sensitive adhesive; or heatsealing; or hot-melt adhesive; or contact adhesive.
 8. The method ofclaim 2, wherein the flexible membranes comprise: silicone; latexrubber; synthetic rubber; polychloroprene; or flexible PVC.
 9. Themethod of claim 2, wherein the seals between the internal mechanicalcomponents and outer shell or a tool attachment portion comprise:removeable seals; or penetrable seals.
 10. The method of claim 2,further comprising returning said limited-use, reusable medical powertool in a bio-hazard contaminated state to a re-supplier or re-processorto be prepared for re-use by cleaning, packaging and sterilizing thetool.
 11. The method of claim 10, wherein said disposable components andthe conforming contamination blocking outer shell are removed andreplaced if needed.
 12. The method of claim 3 wherein the secondaryconforming contamination blocking element, wrap, bag or layer used tocover and further protect the reusable medical biohazard-contaminatedpower tool for return to a tool re-processor is removed and replaced.13. The method of claim 10, wherein the returned and reprocessed tool isplaced in a new packaging and re-sterilized prior to being shipped backout to a user.
 14. The method of claim 11, wherein the reprocessed toolis placed in a new packaging and re-sterilized prior to being shippedback out to a user.
 15. The method of claim 1, wherein the useful lifeof the limited-use, reusable medical power tool ranges from more thanone use to less than 30 surgeries.
 16. The method of claim 1, whereinthe useful life of the limited-use, reusable medical power tool rangesfrom more than one use to less than 20 surgeries.
 17. A method ofprocessing a battery-operated medical power tool used in surgery, saidmethod comprising: providing a limited-use, reusable medical power toolcomprising a combination of re-useable and disposable components andhaving a replaceable contamination-blocking, closely conforming materialouter shell cover mounted over the rigid body mechanical housing, thecover being a removable and disposable shrink-wrap contaminationblocking cover, configured for removal and replacement; returning thebattery-operated limited-use reusable medical power tool to are-supplier or re-processor; replacing disposable components, if needed;cleaning the limited-use, reusable medical power tool; repackaging thelimited-use, reusable medical power tool; and re-sterilizing thelimited-use, reusable medical power tool; wherein the number ofsurgeries where the useful life of the tool ranges from more than oneuse to less than 50 surgeries.
 18. The method of claim 17, wherein saiddisposable components are selected from the group consisting essentiallyof: an outer shell mounted over the mechanical components, the outershell being a conforming contamination blocking outer shell; flexiblemembranes; or seals between the internal mechanical components and theouter shell or a tool attachment portion; or fasteners; or moldedfeatures; or adhesives in multiple forms; or a trigger; or a battery; ora chuck or blade adapter; or a forward/reverse switch; and wherein thereusable internal mechanical components having a first shape and theconforming contamination blocking outer shell having a second shapesubstantially matching and substantially covering the first shape suchthat the outer shell includes a tool attachment portion, a handleportion and a power source portion.
 19. The method of claim 17, whereinthe useful life of the limited-use, reusable medical power tool rangesfrom more than one use to less than 30 surgeries.
 20. The method ofclaim 17, wherein the useful life of the limited-use, reusable medicalpower tool ranges from more than one use to less than 20 surgeries.